What are the precautions for Bedaquiline?

Bedaquiline () is a diarylquinoline antimycobacterial drug that is considered part of combination therapy for multidrug-resistant tuberculosis (MDR-TB) and should be reserved when an effective TB treatment regimen is unavailable. Bedaquiline should only be used in combination with at least 3 other drugs to which the patient's MDR-TB isolates may be susceptible in vitro; if in vitro test results are not available, it may be used in combination with at least 4 other drugs to which the patient's MDR-TB isolate may be susceptible.

Addition of bedaquiline to multidrug regimens may increase liver-related adverse reactions, Avoid alcohol and other hepatotoxic drugs, especially in patients with impaired liver function. Monitor symptoms(such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly)and laboratory tests(ALT, AST, alkaline phosphatase, and bilirubin); test for viral hepatitis and discontinue other hepatotoxic medications if new or worsening liver dysfunction occurs. MonitorALT, AST, alkaline phosphatase, and bilirubin at baseline and monthly during treatment. If transaminases are elevated 2 timesULN or if transaminases are elevated > 8 foldULN or if transaminase elevations persist for more than 2 weeks discontinue bedaquiline.

May prolong the QT interval, obtain an electrocardiogram before starting treatment and at least 2, 12 and 24 weeks after starting treatment. Obtain baseline serum levels of potassium, calcium, and magnesium and correct if abnormal and perform follow-up electrolyte monitoring if QT interval prolongation is detected. Increased risk of QTinterval prolongation, with QT prolonging drugs(such as fluoroquinolones, macrolides class, clofazimine)combined use, if the following conditions occur, use should be discontinued bedaquiline and othersQTprolonging drugs, such as clinically significant ventricular arrhythmias or QTcFinterval> 500ms or monitor the ECG to confirm QTinterval returns to baseline and perform ECG if syncope occurs.

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